GSK says its investigational hepatitis B drug bepriovirsen met the primary endpoint in two pivotal Phase 3 trials, with regulatory submissions schedul...
FDA says it cant approve a Vanda sNDA for Hetlioz to treat jet lag disorder in its current form.
Moonlake Immunotherapeutics says that, based on recommendations from a meeting with FDA, it will submit a BLA in the second half of 2026 for sonelokim...
FDA commissioner Marty Makary promotes limited regulatory scrutiny of many wearable devices and software tools, a significant policy shift aimed at mo...
FDA says the Abiomed 6/23/2025 correction to user instructions for its Automated Impella Controllers was Class 1.
FDA warns Wilington, DE-based Agebox about selling misbranded unapproved new drugs.
FDA warns Melbourne, FL-based Absolutely Natural about CGMP violations in its production of finished drugs.
